TransCelerate BioPharma Launches Second Year Initiatives, Expands Membership and Achieves Milestones for Original Projects

PHILADELPHIA, Nov. 7, 2013 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate") is launching three new global initiatives to further advance efficiency in clinical trials and accelerate the development of new medicines: creation of common clinical trial protocol templates, development of clinical trial networks for pediatric and minority populations, and establishment of a global investigator registry.

TransCelerate is also expanding two of its original five initiatives, the Clinical Trial Comparator Network and the Site Qualification & Training project, based on the success of the programs.

In addition, Cubist Pharmaceuticals has joined the organization, bringing the member total to 18. Since the September 2012 launch, eight new companies have joined TransCelerate's ten founding members.

"While TransCelerate is not the first organization or consortium that the biopharmaceutical industry has formed to solve common challenges, it is one of the most ambitious and supported collaborations to date. We have not only set goals, but we have delivered on these goals in just over one year since we were incorporated," said Dalvir Gill, PhD, Chief Executive Officer of TransCelerate. "Our focus in this second year will be to expand upon our principles of collaboration among the organization's member companies to address new initiatives directed at resolving common challenges impeding R&D in the industry, and expand the scope and success of our original work."

The new TransCelerate initiatives are:

Common Clinical Trial Protocol Templates The format of clinical trial protocols varies from company to company making interpretation difficult for trial sites, institutional review boards (IRBs), and regulators. These protocols have become increasingly complex, as no agreed upon standards exist, driving up cost and time. In addition, manual set-up of clinical systems based on non-standard "manual" protocols is time consuming, costly, and prone to error.Working with other industry stakeholders and regulators, TransCelerate seeks to standardize the format of clinical trial protocols and develop standards for required protocol endpoints, in alignment with the ongoing TransCelerate Clinical Data Standards project. This will simplify study protocols, facilitate data interpretation and enable down-stream automation of many clinical processes, increasing productivity and reducing costs.

Special Populations Clinical Trial Networks (Pediatric and Minority) Presently, qualified investigators with adequate numbers of patients in these populations are difficult to find, and studies in these areas are typically exceptionally costly and lengthy. Especially in pediatrics, efforts to establish a network of investigators and sites are often repeated for each clinical trial and then dispersed after a trial is completed. With this initiative, TransCelerate, working closely with existing regional networks, will lead the development of global investigator networks for these populations which will result in accelerated development of new drugs or indications for children, adolescents and minorities as well as reduced clinical trial costs.

Investigator Registry Clinical trial sponsors frequently invest significant time and resources in identifying qualified investigators and establishing study sites. The inability to obtain information on investigator sites' experiences and qualifications often delay crucial trials. TransCelerate's Investigator Registry will create a shared repository of investigator contact details and site-related data. This initiative builds on TransCelerate's Shared Portal Project, and accelerates identification and recruitment of qualified investigators, which will avoid duplication of standard site qualification and creation of investigator documentation, and thereby reducing cost and trial length.

In addition to the three new initiatives, TransCelerate will expand on two successful projects that were part of the original five initiatives:

Site Qualification and Training To build upon the creation of common criteria for mutual recognition of GCP training and common forms to collect generic information about study sites, TransCelerate will provide a common framework to streamline the process for qualifying investigator sites, , and standardizing non-protocol specific forms for clinical trials. The organization will also establish criteria for training site personnel new to clinical research and trials.

Comparator Network To enhance the value of the network, TransCelerate will expand on the current offerings to include products for clinical trial blinding: active & placebo, devices and bulk commercial products. The organization will also include the option of product discounts and expansion of the network in other regions of the world.

The new initiatives and extensions expand on the scope and success of the original TransCelerate initiatives, which have provided the following advances for both industry and patients:

A published framework and approach for Risk-Based Monitoring (RBM); launch of pilot studies for RBM across multiple member companies and therapeutic areas

Established criteria for Site Qualification & Training, in support of mutual recognition of GCP training and development common forms to collect generic information about study sites

"We are very pleased to see the power of collaboration at work for the benefit of patients," said Paul Stoffels, MD, Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals at Johnson & Johnson, and Interim Chairman of the Board for TransCelerate. "TransCelerate has made significant gains in improving clinical trial efficiencies and streamlining the drug development process, and we are excited by the opportunities for continued progress toward our ultimate goal of improving patient health."

About TransCelerate BioPharma Inc.

TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organizations' mission is to collaborate across the global R&D community to identify, prioritize, design and implement solutions designed to drive the efficient, effective and high quality delivery of innovative new therapies. TransCelerate evolved from discussions at various forums for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. Founding members include AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi, and all have representation on the Board of Directors. Additional members include Astellas Pharma Inc., Biogen Idec, Braeburn Pharmaceuticals, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Onyx Pharmaceuticals, Inc., an Amgen subsidiary, and UCB.

Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.